Laboratories use a variety of laboratory management systems to integrate laboratory software and instruments; to manage samples, laboratory users, and standards; to control other laboratory functions such as Quality Assurance (QA) and Quality Control (QC); to conduct sample planning, invoicing, and plate management; and to manage workflow. Laboratory management systems can include a variety of different types of systems for managing samples, information and/or instruments within a laboratory, such as a Laboratory Information System (LIS), a Process Development Execution System (PDES), and a Laboratory Information Management System or Laboratory Integration Management Solution (LIMS).
A Laboratory Information System (“LIS”) is a class of software that receives, processes, and stores information generated by medical laboratory processes. LIS systems often must interface with instruments and other information systems such as hospital information systems (HIS).
A Process Development Execution System (PDES) is a system which is used by companies to perform development activities for manufacturing processes.
A Laboratory Information Management System or Laboratory Integration Management Solution (LIMS) is a software system used in laboratories for the integration of laboratory software and instruments and the management of samples, laboratory users, standards and other laboratory functions such as Quality Assurance (QA) and Quality Control (QC), sample planning, invoicing, plate management, and workflow automation. LIMS systems may also support information gathering, decision making, calculation, review and release into the workplace and away from the office. More recently, LIMS systems are starting to expand into Electronic Laboratory Notebooks, assay data management, data mining and data analysis.
Modern laboratory management systems have implemented extensive configurability as each laboratories needs for tracking additional data points can vary widely. Vendors of laboratory management systems often cannot make assumptions about what these data tracking needs are and therefore need to be adaptable to each environment. Users of laboratory management systems may also have regulatory concerns to comply with such as CLIA, HIPAA, GLP, ISO 17025, ASCLD Supplement, and FDA specifications and this can affect certain aspects of sample management in a laboratory management system. One key to compliance with many of these standards is audit logging of all changes to data of laboratory management systems, and in some cases a full electronic signature system is required for rigorous tracking of field level changes to data of laboratory management systems.
Laboratory management systems may be customized for use in a wide variety of settings and laboratories, such as medical or clinical laboratories, biological laboratories, chemistry laboratories, chemical or petroleum laboratories, commercial or manufacturing use, forensics or crime laboratories, pathology laboratories, public safety and public health laboratories, and water processing and testing facilities.
A user may configure a laboratory management system whereby users are assigned roles or groups. Typically the role of a user will dictate their access to specific data records in the laboratory management systems. Each user account is protected by security mechanisms such as a user id and a password. Users may have customized interfaces based on their role in the organization. For example, a laboratory manager might have full access to all of a laboratory management system's functions and data, whereas technicians might have access only to data and functionality needed for their individual work-tasks.
Some laboratory management systems offer some capability for integration with instruments. A laboratory management system may create control files that are “fed” into the instrument and direct its operation on some physical item such as a sample tube or sample plate. The laboratory management system may then receive information generated by the instrument and extract QC information, results information, or status information for assessment of the operation on the sample or samples. Data owners may access the resulting stored information at any time.
As instruments are being operated, instrument status may change from being in a first operating state to being in a second operating state. The instrument status of an instrument describes what operating state an instrument is operating within. Operating states describe the current operation of an instrument and include things such as an initialization state where the instrument is initialized upon powering on the instrument, an on state where the instrument is powered on and initialized, an off state where the instrument is powered off, a restart state where the instrument is restarted after being in the on state, a pause state where the instrument is in the on state but not receiving or generating information, a clear queue state where the instrument clears its memory of some or all received commands, and a usage state where the instrument is in use and conducting a task or performing a test. As the instrument status changes, the instrument generates instrument status information to indicate the current instrument status of an instrument. Additionally, as the instrument is being operated throughout the day, the instrument generates QC information for QC samples. All QC samples are grouped by lot number of the QC as well as level (i.e. high or low).
As instruments are being used and accessed within a laboratory, often times their instrument status is unknown to a user of the laboratory management system. As a result, the user is often unaware if an instrument within a laboratory is available for use or not. It would be desirable to provide a user with a graphical representation of the status an instrument within the laboratory management system and displayed on a display so that the user can visually and quickly check the status of an instrument. Additionally, it would be desirable to provide a user with information presented in a graphical manner which details how often an instrument is in or not in a particular state, for example how long an instrument in being used and therefore in the usage state. Additionally, it would be desirable to provide a user with information presented in a graphical manner which details the QC results of a particular instrument.